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It is official the application has been submitted to the FDA for approval. I was told this process takes 6-9 months. Wish this was done 6-9 months ago when the test was completed, but they had to rethink the application since the test endpoints were poorly defined. I am very thankful that...

At first, I was a little confused about the results from this 4 week study. Here is my summary of what happened. They took people who were already taking Kalydeco and then also gave some of them VX-661. These people had one gene that was DelF508 and the other gene was one of the G551D...

Good news for approx. 150 people with CF 6 and older. a supplemental New Drug Application (sNDA) for KALYDECOTM (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who have one of eight additional mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene...

Is it just me or was this study poorly defined, providing misleading results? I understand this was a difficult study to perform with so few participants, but it should have been tailored to the population. They took patients under 12 who had FEV1 between 40 - 105% and patients above that...